Regulatory Open Forum

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  • 1.  Packaging and labeling of drug products for non-clinical use

    Posted 24-Apr-2017 00:38
    Good morning!

    One of our clients wants to sell an approved drug product (protein) for use as an excipient in the formulation of another drug product or as a component in a cell culture. The following questions came up:

    General: Are there any regulations/guidelines for selling registered drug products for non-clinical use, e.g. as, excipients? What needs to be fulfilled to import such products (e.g. US, EU)? Are there any licenses required to purchase prescription-only drug products even for non-clinical use? 

    Packaging/labeling: what are the regulatory requirements for packaging of approved drug products for non-clinical use? Can the product be sold in its original packaging and only be marked "for non-clinical use"? Are there any particular requirements / guidances? Does e.g. a sticker need to be put on the packaging (carton and vial label) to distinguish it from the approved drug product? Is it OK to ship it without PIL? 

    Your input is highly appreciated!

    Cheers, Beat



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    Beat U. Steffen
    Founder & CEO
    confinis ag
    Duedingen
    Switzerland
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  • 2.  RE: Packaging and labeling of drug products for non-clinical use

    Posted 24-Apr-2017 23:26
    Below is my thoughts based on my experience and your case. This is only my input. Please seek an expert advice before making any decision.

    1) If its a approved drug product, it means it possess pharmacological activity and hence it could not be serve the purpose of excipient.

    2) this could be a case of combination product - i.e. drug & biologic or similar.

    3) As a drug manufacturer you can import the drug based on your manufacturing licence for research and development purpose. You have to keep the documentation like purchase order, invoice, sample information, etc.

    4) It can not be distributed by your firm with other company`s label. If it serve as a combination product then it needs to be under agreement with other company or else you have to develop your own label and get it approved from the regulatory agency.


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    Gaurang Bhavsar
    Edison NJ
    United States
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  • 3.  RE: Packaging and labeling of drug products for non-clinical use

    Posted 27-Apr-2017 01:16
    From a European perspective, my opinion is different to Gaurang's. To be considered a medicinal product in the EU, the product must be presented as having properties for treating or preventing disease; or be used with a view to restoring, correcting or modifying physiological
    functions or to making a medical diagnosis (my emphasis is added).  The protein in question <g class="gr_ gr_1147 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation replaceWithoutSep" id="1147" data-gr-id="1147">may therefore</g> qualify as an excipient because by virtue of the way in which it is marketed or presented, or its intended use.  Thus I doubt that a protein sold in bulk qualifies as a medicinal product,  but as always, I would suggest you speak to a European regulator eg the MHRA who are very helpful.
    By the way, a <g class="gr_ gr_2030 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="2030" data-gr-id="2030">terapeutic</g> protein does not <g class="gr_ gr_2024 gr-alert gr_gramm gr_inline_cards gr_disable_anim_appear Style multiReplace" id="2024" data-gr-id="2024">necessarily  </g><g class="gr_ gr_2024 gr-alert gr_gramm gr_inline_cards gr_disable_anim_appear Style multiReplace" id="2024" data-gr-id="2024">have</g> any pharmacological activity, for example, albumin.  Additionally, many excipients have pharmacological activities too e.g. ascorbic acid (vitamin C) - it all depends on the amount and the claims made for the medicinal product.
    Regards, Steve

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    Steve Binysh
    Acta Pharma Services Ltd
    RUISLIP
    United Kingdom
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